You are on page 1of 4

No.

QP/22
Tove Leeds Certification and Inspection
Issue No. 00
Quality Procedure Date 13–12–2021

Procedure
For
Application of decision rule
Controlled Copy No.
Issued to
Issued by Quality Manager
Revision details
Issue
Issued on Details of amendment / revision made Reason for amendment
No.

Due to implementation of
00 13-12-2021 First issue
ISO/IEC 17025

Prepared By Approved By Signature Page


Technical Manager Quality Manager 1 of 4
[
No. QP/22
Tove Leeds Certification and Inspection
Issue No. 00
Quality Procedure Date 13–12–2021
1.0 Purpose
The purpose of this procedure is to describe the procedure for the providing the statement
of conformity and application of decision rule.
2.0 Scope
2.1 This procedure covers all the certificates issued by laboratory for the parameters accredited
under ISO/IEC 17025:2017.
3.0 Responsibility
3.1 Technical Manager is responsible for providing the statement of conformity based on the
customer request at the time of review of request and application of decision rule as agreed
with customer.
4.0 Description of Activity
4.1 Statement of conformity and application of decision rule
The following procedure is followed during providing the statement of conformity and
application of decision rule.
4.1.1 As soon as the calibration service request and instrument receipt challan from the customer is
received for providing statement of conformity, the same is reviewed by Technical
Manager / Authorized person for the followings.
 Against which standards, such as accuracy / acceptance criteria,
 The confirmation from the customer is taken for the accuracy / acceptance criteria to be
used for providing the statement of conformity.
4.1.2 Once the accuracy / acceptance criteria for conformity are defined the same are recorded in the
calibration service request and instrument receipt challan at the review of request stage.
4.1.3 Technical Manager person will inform the customer for the application of decision rule and will
be informed that while providing statement of conformity the measurement uncertainty will
be taken into consideration. The same will be agreed with the customer and will be reported
in the calibration service request and instrument receipt challan.
4.1.4 Customer will be informed and communicated for the applicability of decision rule and
consideration of measurement uncertainty.
4.1.5 Once it is agreed by customer the equipment will be received and will be calibrated at
laboratory. After calibration the results obtained during calibration will be evaluated against
the accuracy / acceptance criteria with the addition of deletion of measurement uncertainty
and based on that the statement of conformity will be provided. For example;
Example–1, For Pass / Accepted (Accuracy / acceptance criteria in the same
measurement unit)
 For Digital Thermometer (Range – 50°C to 300°C, Resolution – 0.1°C) the accuracy /
acceptance criteria is given as ± 0.3°C.
 The measurement uncertainty obtained during calibration is ± 0.05°C.
 The results obtained after calibration at 100°C is 100.1°C
* In this case the accuracy / acceptance criteria will be ± 0.3°C The error obtained at the
end of calibration is 0.1°C. Means after addition of uncertainty the results will be 100.15 °C

Prepared By Approved By Signature Page


Technical Manager Quality Manager 2 of 4
[
No. QP/22
Tove Leeds Certification and Inspection
Issue No. 00
Quality Procedure Date 13–12–2021
and after subtraction of uncertainty the results will be 100.05°C. Hence in this case the
same is within the accuracy / acceptance criteria of ±0.3°C. Hence the Digital
Thermometer is concluded as “Pass / Accepted” at the end of calibration.
Example–2, For Fail / Reject (Accuracy / acceptance criteria in the same
measurement unit)
 For Digital Thermometer (Range –50°C to 300°C, Resolution – 0.1°C) the accuracy /
acceptance criteria is given as ± 0.3°C.
 The measurement uncertainty obtained during calibration is ± 0.08°C.
 The results obtained after calibration at 100°C is 99.5°C
* In this case the accuracy / acceptance criteria will be ± 0.3°C The error obtained at the
end of calibration is 0.5°C. Means after addition of uncertainty the results will be 99.58°C
and after subtraction of uncertainty the results will be 99.42°C. Hence in both the cases,
the same is outside the accuracy / acceptance criteria of ±0.3°C. Hence the Digital
Thermometer is concluded as “Fail / Rejected” at the end of calibration.
Example–3, Difficult to provide statement (Accuracy / acceptance criteria in the
same measurement unit)
 For Digital Thermometer (Range –50°C to 300°C, Resolution – 0.1°C) the accuracy /
acceptance criteria is given as ± 0.3 °C.
 The measurement uncertainty obtained during calibration is ± 0.06°C.
 The results obtained after the calibration at 100°C is 100.3°C.
* In this case the accuracy / acceptance criteria will be ± 0.3°C. The error obtained at the
end of calibration is 0.3°C. Means after addition of uncertainty the results will be 100.36°C
and after subtraction of uncertainty the results will be 100.24°C. Means if the uncertainty is
added into the results, then the same is to be concluded as “Fail/Rejected” and if the
uncertainty is subtracted then the same is to be concluded as “Pass / Accepted”. Hence in
this case it is difficult to provide statement of conformity and hence in this case laboratory
will not give any conformity and just report the calibration results with the measurement
uncertainty. Customer will decide for statement of conformity in these types of situations.
Technical Manager will evaluate and will provide statement of conformity after applying
measurement uncertainty as a decision rule as per the example given above. The
statement of conformity will be reported in the calibration certificate with the statement
clearly identifies as below.
 Parameters / values considered for providing statement of conformity,
 Accuracy / acceptance criteria used for providing the statement of conformity,
 Decision rule applied, means the measurement uncertainty is applied for providing the
statement of conformity. In this case, the final conclusion after considering
measurement uncertainty will be drawn. If customer wants, then the result obtained
during the calibration and measurement uncertainty will be given separately for his
interest.

Prepared By Approved By Signature Page


Technical Manager Quality Manager 3 of 4
[
No. QP/22
Tove Leeds Certification and Inspection
Issue No. 00
Quality Procedure Date 13–12–2021

5.0 References
6.0 ILAC-G8:09/2019 Guidelines on decision rules and statement of conformity
7.0 Enclosures Nil
8.0 Formats / Exhibits Nil

Prepared By Approved By Signature Page


Technical Manager Quality Manager 4 of 4
[

You might also like